Validation Engineer
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our teams achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech its about more than just a jobits about your career and your future.
Your Role
We are hiring an experienced Validation Engineer to support equipment process software and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably safely and in compliance with cGMP Annex 11 and global regulatory standards. This role involves planning writing implementing and executing validation protocols to ensure consistent product quality and regulatory compliance.
- Perform execution of validation protocols including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for equipment and systems.
- Generate and execute validation documentation for manufacturing equipment utilities and computerized systems in accordance with cGMP GxP and Annex 11 requirements.
- Support CQV activities for sterile injectable manufacturing equipment and site utilities ensuring seamless integration and qualification.
- Lead CSV efforts including risk assessments validation plans and test scripts for computerized systems to maintain data integrity.
- Validate and qualify various equipment and utilities i.e Depyrogenation Ovens
- Troubleshoot and resolve issues related to validated equipment processes and systems; implement CAPA as needed.
- Maintain accurate validation documentation and ensure audit readiness.
- Additional responsibilities as assigned to drive project success.
Requirements
- Bachelors degree in Engineering (Mechanical Chemical or related field) or Life Sciences.
- 45 years of validation experience within pharmaceutical biotech or medical device industries.
- Strong knowledge of CSV and CQV principles including regulatory expectations for sterile injectable manufacturing.
- Familiarity with Annex 11 data integrity requirements and industry standards such as ASTM E2500 ISPE Baseline Guides and cGMP regulations.
- Experience with equipment cleanroom systems HVAC purified water compressed air and other critical utilities.
- Proficiency in writing and executing IQ/OQ/PQ protocols validation reports and computerized system validation documentation.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Strong time management and organizational skills.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- Must be authorized to work in the US.
- No C2C at this time.
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more. - 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $90000 to $125000 annually. The offered salary may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicants employees or interns actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
Required Skills:
Enrolled in related technical degree programs i.e. Computer Science Networking System Administration etc. Familiar with networking fundamentals (TCP/IP VLANs Cisco switches/firewalls). Basic understanding of virtualization concepts (VMware preferred). Demonstrated knowledge of Windows Server administration (Linux is a plus). Must be local to York PA. Must be able to intern minimum of 15-20 hours per week during academic semester. Strong problem-solving skills and attention to detail. Strong drive and willingness to learn in a regulated environment. Detail-oriented with a commitment to accuracy and quality. Enthusiasm for learning and growth.
Company Industry
IT Services and IT Consulting
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
